Chapter 12 - IHS Employee Immunization Program

1-12.1 INTRODUCTION

1. Purpose . This chapter establishes policy regarding mandatory occupational immunizations for Indian Health Service (IHS) personnel to:
   1. Protect patients from vaccine-preventable diseases that may be transmitted from infectious personnel.
   2. Protect all IHS personnel (including those at elevated risk), their families, and their contacts from vaccine-preventable diseases.
2. Background . The IHS personnel who are well-informed about vaccine- preventable diseases and are fully immunized will experience better health, fewer absences, and have reduced risk of acquiring or becoming severely ill from vaccine-preventable diseases or transmitting them to IHS patients, fellow workers, and the general public. Personnel working at health care facilities and in certain community settings are at increased risk of exposure to vaccine- preventable diseases. Ensuring and maintaining immunity is essential to maintaining employee health, patient safety, and preventing the spread of infection. Pursuant to 25 U.S.C. § 1661, the IHS Director is responsible for the operation and maintenance of IHS facilities and is vested with the authority to issue this policy to carry out such functions. In accordance with 42 C.F.R. § 136.3, the directives contained herein are operating procedures to assist officers and employees in carrying out their responsibilities, and are not regulations establishing program requirements that are binding upon members of the general public.
3. Definitions .
   1. Employee Health Coordinator (EHC) . Personnel routinely charged with managing infection control and/or the employee health program within any IHS health care facility.
   2. Employee Health Record . A component of the Federal Employee Medical File System of Records (OPM/GOVT-10) that is locally maintained and separate from patient medical records contained within the IHS medical, health, and billing system.
   3. Health Care Facility . Any Federal IHS hospital, clinic, or health station.
   4. Health Care Facility Personnel (HCFP) . All Civil Service employees, Commissioned Corps Officers of the United States Public Health Service (USPHS), contract staff, temporary employees, students, residents, and volunteers whose duties and responsibilities require them to work permanently, temporarily, or occasionally in an IHS health care facility are considered HCFP, regardless of their job category or level of patient contact. Personnel permanently assigned elsewhere but working in or visiting an IHS health care facility in any official capacity, regardless of duration, are considered HCFP under this policy.
      
      Commissioned Corps Officers of the USPHS are also required to obtain and maintain routine immunizations to comply with USPHS readiness standards.
   5. Influenza Season . November 1 through March 31 each year, though it may include other periods of increased levels of influenza activity as determined locally by health care facility leadership.
   6. Licensed Independent Health Care Practitioner (LIHCP) . Any individual permitted by law and IHS policy to provide care, treatment, and services without direction or supervision. A LIHCP provides medical care within the scope of the individual’s license and consistent with individually granted clinical privileges.
   7. Serologic Evidence of Immunity . Refers to the result of a blood test that indicates the presence of sufficient antibodies indicative of immunity to a specific infectious disease (also referred to as a positive titer). Unless otherwise determined by the Centers for Disease Control and Prevention (CDC), serologic evidence of immunity is acceptable regardless of the date determined, does not expire, and therefore, does not need to be repeated at any subsequent date.
4. Policy . It is the policy of the IHS that:
   1. All HCFP must be fully immunized against vaccine-preventable diseases consistent with current CDC recommendations for health care workers. To be considered fully immunized, HCFP must receive the number of vaccine doses, including any subsequent doses at prescribed intervals (e.g., annual flu vaccine), as recommended by the CDC for each vaccine.
   2. Required Vaccines for All HCFP :
      1. Seasonal influenza (annually by October 31);
      2. Measles, mumps, and rubella (MMR);
      3. Varicella (chicken pox); and
      4. Tetanus, diphtheria, and acellular pertussis (Tdap) or Tetanus and diphtheria (Td).
   3. Required Vaccines for Select HCFP with Specific Occupational Risk :
      1. Hepatitis B . HCFP with a recognized risk for contact with blood, bodily fluids, or other potentially infectious materials through the performance of their regular duties are required to be fully immunized against the hepatitis B virus. This includes, but is not limited to, all HCFP with direct clinical patient care responsibilities, laboratory personnel handling patient specimens, and housekeeping and custodial staff who routinely handle potentially infectious materials (e.g., soiled linens, contaminated sharps disposal).
         1. Post-vaccination serologic testing for hepatitis B surface antibody (anti-HBs) is not required. However, it is recommended to confirm sufficient immune response following completion of a hepatitis B vaccine series. Such testing provides reasonable assurance of protection for HCFP if subsequently exposed to hepatitis B virus and informs appropriate post-exposure assessment and response based on documented immune status. Additional hepatitis B vaccination and repeat anti-HBs testing may be recommended for HCFP demonstrating insufficient immune response to hepatitis B vaccination. For HCFP without a documented history of ever being tested for hepatitis B infection, expanded testing to include hepatitis B surface antigen and total antibody to hepatitis B core antigen in addition to anti-HBs (collectively, ‘triple screening’) may be beneficial.
      2. Meningococcal . HCFP who may be routinely exposed to meningococcal isolates (e.g., clinical microbiologists) are required to receive meningococcal vaccines (vaccine(s) containing both MenACWY and MenB).
   4. Recommended Vaccine for HCFP and Other Personnel with Specific Occupational Risk :
      1. Rabies . The EHC should assess the risk of rabies and exposure for personnel routinely working with animals or performing field investigations or home visits in communities where animal exposures may occur. Those determined to be at increased risk should receive rabies pre-exposure prophylaxis through vaccination.
   5. Timely Seasonal Influenza Vaccination . The IHS Headquarters Chief Medical Officer (CMO) may extend the vaccination deadline of October 31 if vaccine supply is inadequate or sufficiently protracted to preclude timely vaccination.
   6. Serologic evidence of immunity is acceptable instead of vaccination for varicella (chicken pox), and measles, mumps, and rubella (MMR).
   7. Presumed Immunity to Measles, Mumps, and Rubella . While HCFP born before 1957 are often presumed immune to measles, mumps, and rubella via natural exposure and infection, all HCFP, including those born before 1957, must receive two doses of MMR vaccine or demonstrate serologic evidence of immunity.
   8. HCFP may request medical or religious exemption from some or all required vaccinations (see section E(2) below regarding exemption requests and adjudication procedures).
   9. HCFP without documented immunity (i.e., proof of full vaccination or sufficient serologic response), an approved medical or religious exemption, or who otherwise refuse to comply with this policy will be subject to disciplinary or administrative actions. These actions can include reassignment, removal from Federal service, termination of contracts or training agreements, or other appropriate disciplinary actions.
   10. All current HCFP with an in-service date before the effective date of this policy must provide acceptable documentation to their EHC substantiating receipt of required vaccinations (or initiation of any required vaccination series), proof of serologic immunity, or request for exemption within 90 days following issuance of this policy. Note that documented receipt of seasonal influenza vaccination is required annually by October 31. Please see section E(1) for a description of acceptable documentation.
   11. All HCFP with an in-service date after the effective date of this policy must provide acceptable documentation to their EHC substantiating receipt of required vaccinations (or initiation of any required vaccination series), proof of serologic immunity, or request for exemption within 30 days of their entrance on duty. This includes seasonal influenza vaccination if the in-service date occurs during or within 30 days of the start of influenza season (i.e., November through March).
   12. The IHS is prohibited from using protected health information (PHI) for employment purposes. Therefore, the EHC is prohibited from accessing an HCFP’s existing patient medical record to verify vaccination history or immune status. The HCFP must directly provide acceptable documentation of immunity or otherwise authorize the release of information from their medical record in accordance with IHS policy.
   13. All vaccinations and serologic testing specifically required or recommended within this policy will be offered and administered to consenting HCFP at no direct cost.
   14. IHS health care facilities will ensure all vaccinations recommended by CDC for health care workers, including COVID-19 vaccination(s), are available to consenting HCFP.
   15. Additional vaccines, additional doses of currently required or recommended vaccines, or other mitigation measures may be directed in certain contingencies to prevent the spread of a communicable disease or to otherwise address imminent public health hazards, including but not limited to a pandemic or other vaccine-preventable disease outbreak.
5. Procedures .
   1. Documentation .
      1. Vaccines Administered by the IHS . At the time of vaccination, the following information should be recorded in the employee health record:
         1. The date of vaccine administration;
         2. Vaccine formulation (i.e., brand);
         3. Vaccine manufacturer;
         4. Dose volume;
         5. Anatomic site of administration;
         6. Vaccine lot number and expiration date;
         7. Name and title of the provider administering the vaccine;
         8. Address of the administering facility; and
         9. That a Vaccine Information Statement (VIS) was provided for each vaccine administered, the date the VIS was provided, and the date printed on the VIS.

         Upon request, HCFP will be provided documentation of vaccines administered.

      2. Vaccines Not Administered by the IHS . HCFP who receive required vaccination(s) from a non-IHS provider must provide written proof of vaccination that sufficiently documents, at a minimum:
         1. The date of vaccination;
         2. Vaccine type and formulation (i.e., brand); and
         3. Name of the provider administering the vaccine.

         This information will be filed with any additional documentary proof of vaccination as part of the employee health record.

   2. Exemption from Vaccination Requirement(s) .
      1. Medical Exemption from Vaccination . Any HCFP may request either temporary or permanent medical exemption from any or all required vaccines. The request must clearly identify the medical contraindication to the vaccination(s) and be accompanied by a corroborating statement signed by a LIHCP. The request will be evaluated consistent with the CDC Advisory Committee on Immunization Practices (ACIP) Contraindications and Precautions to Commonly Used Vaccines, or similar resources, as well as consistent with the processing of reasonable accommodations. Based on current guidance, valid medical contraindications to specific vaccines vary but may include a history of severe allergy or life-threatening allergic reactions to any vaccine component, concurrent severe illness, immunosuppression, and pregnancy, as determined by CDC. HCFP are encouraged to consult with their medical provider regarding their particular medical situation and suitability for receiving specific vaccines, including during pregnancy. Additional medical conditions and/or precautions for vaccination not explicitly identified as contraindications may be considered for medical exemption if the HCFP’s LIHCP determines that vaccination may pose a substantive risk to the patient.
         1. The Request for a Medical Exemption Must Include the Following Information :
            1. A statement, signed by a LIHCP to the HCFP’s EHC, affirming that a valid medical contraindication exists that precludes vaccination. The LIHCP’s statement must clearly categorize the contraindication as either temporary or permanent in nature. For temporary contraindications (e.g., pregnancy), the anticipated duration of the medical contraindication with the expected end date must be clearly stated.
            2. A clear statement indicating which required vaccine(s) the contraindication request applies.
         2. Timely Submission . See Procedures section D(10) for current employees and D(11) for new employees. For influenza vaccination, exemption requests must be submitted to the EHC by October 31 annually.
      2. Religious Exemption from Vaccination . Any HCFP who asserts their sincere religious beliefs prohibit immunization with one or more required vaccine(s) may request an exemption from IHS’s vaccination requirements.
         
         Request for a religious exemption must include a written statement signed by the HCFP to the HCFP’s EHC explaining how the vaccination requirement(s) contradicts their sincere religious beliefs. Statements must also identify which specific vaccine(s) are requested for exemption.
      3. Adjudication of Exemption Requests . The EHC will receive, review, and approve or deny exemption requests consistent with the IHS’s process for handling reasonable accommodation requests. The EHC will consult with Human Resources and the Office of the General Counsel when necessary. All HCFP requesting a medical or religious exemption will receive written notice, either approving or denying the request, within fourteen calendar days of IHS receiving the request. Notice of adjudication outcome to HCFP will be provided solely by email correspondence. Approved religious and temporary medical exemptions will have a clearly delineated expiration date, as applicable (see Section E(2)(f) below regarding exemption duration). HCFP whose request for an exemption is denied must receive the required vaccination(s) or initiate an appeal within fourteen calendar days of issuance of the denial notification (i.e., email notification date and time stamp). All denial notifications issued to HCFP shall include an explanation of the denial, right to appeal, appeal procedures, and timing requirements, as well as a statement regarding the potential consequences for non-compliance with this Policy as described in Section F. All exemption requests and documented adjudication outcomes will be maintained as part of the employee health record.
      4. Appeal of Exemption Denials .
         1. Method and Timing of Appeals .
            1. All appeal requests shall be in writing and submitted by the HCFP to their EHC for routing to the appropriate adjudicating official as outlined below. Appeal requests submitted via email are acceptable.
            2. All appeals (primary and secondary) must be initiated within 14 calendar days of issuance of each denial notification (i.e., denial notification email date and time stamp). Otherwise, the opportunity to appeal is forfeited.
         2. Medical Exemption Requests .
            1. Primary Appeal . When requested by HCFP, the facility’s Clinical Director or Service Unit CMO will reconsider denied medical exemption requests.
            2. Secondary Appeal . If a primary appeal is denied, HCFP may request the Area CMO or their designee reconsider denied medical exemption requests. The decision of the Area CMO or their designee is final and concludes the appeals process.
         3. Religious Exemption Requests .
            1. Primary Appeal . When requested by HCFP, the facility’s Chief Executive Officer (CEO) will reconsider denied religious exemption requests.
            2. Secondary Appeal . If a primary appeal is denied, HCFP may request the Area Director or their designee to reconsider denied religious exemption requests. The decision of the Area Director or their designee is final and concludes the appeals process.
      5. HCFP with a Pending Exemption Request, Approved Exemption, or Active Appeal . Unvaccinated HCFP with pending or approved exemption or active appeal who are exposed to, infected with, or otherwise at elevated potential risk for propagating certain vaccine- preventable diseases, must strictly adhere to any mitigating infection-control practices as directed by health care facility leadership, which may include but not be limited to masking or reassignment.
         1. Health care facility leadership may direct targeted or universal masking of HCFP as an infection control measure during any period of actual or perceived risk for increased transmission of infectious diseases, including but not limited to COVID-19 and influenza. This can occur at any time regardless of season given the dynamic transmissibility for many infections. The IHS will gather information internally and from CDC, Tribal, and/or state public health authorities regarding trends in patient illness, hospitalizations, transmission rates, and other relevant information to determine the degree of transmission risk.
      6. Duration of Exemption .
         1. Temporary Medical Exemptions . Approved temporary medical exemptions are valid for the lesser time of either:
            1. The anticipated duration of the attributing medical condition as documented in the supporting LIHCP’s statement; or
            2. For one year.

               Temporary medical exemptions are valid for one year from the date of approval, unless a lesser duration is indicated in the supporting LIHCP’s statement. Any temporary contraindication lasting greater than one year must be renewed annually.

               HCFP must notify their EHC if a medical condition for which a temporary exemption is granted resolves prior to the original exemption expiration.

               Approved exemption from seasonal influenza vaccination is considered a temporary exemption. HCFP must obtain a new exemption each year by October 31, regardless of prior issuance date (i.e., initial exemption may be valid for periods of less than one year).

         2. Permanent Medical Exemptions . Approved exemptions for permanent medical contraindications, as documented in the supporting LIHCP’s statement, are likewise considered permanent, have no expiration date, and do not require periodic review or renewal.
         3. Religious Exemption . An approved religious exemption is valid for one year and must be renewed annually.
      7. Renewal of Exemption . To maintain compliance with this policy, HCFP with an approved religious or temporary medical exemption must reapply for subsequent exemption(s) prior to the expiration of the current exemption or receive the required vaccinations or otherwise prove immunity. The procedures outlined in section E(2) for requesting an exemption are applicable to both initial and subsequent requests for exemption (renewal).
6. Compliance . Personnel who refuse to comply with this policy and do not have an approved medical or religious exemption are subject to disciplinary action in accordance with Department of Health and Human Services and/or IHS policy and relevant sections of collective bargaining agreements, as applicable.
7. Responsibilities .
   1. Area Director.
      1. Implements all requirements of this policy and ensures that all HCFP in their Area are compliant. The Area Director may direct action by or delegate responsibility to any suitable senior Area- level staff to ensure compliance with this policy.
      2. Ensure consistency in the implementation of this policy across all Area health care facilities.
      3. Adjudicates secondary appeals for previously denied religious exemption requests submitted by Area HCFP or designates alternate staff to perform such adjudication.
      4. Consults with Human Resources and the Office of the General Counsel as necessary to comply with all applicable laws.
   2. Area Chief Medical Officer .
      1. Adjudicates secondary appeals for previously denied medical exemption requests submitted by Area HCFP or designates qualified staff to perform such adjudication; determines if documentation of vaccinations or immunity is sufficient to meet the requirements of this policy.
      2. Consults with Human Resources and the Office of the General Counsel as necessary to comply with all applicable laws.
   3. Facility Chief Executive Officer .
      1. Establishes procedures to provide required vaccinations and necessary recordkeeping.
      2. Ensures that all personnel are aware of the health risks of vaccine- preventable diseases to themselves and patients.
      3. In coordination with the facility’s Chief Medical Officer and/or Clinical Director, determines periods of actual or perceived risk for increased transmission of infectious diseases, including but not limited to COVID-19 and influenza; directs institution of mitigating infection control practices as necessary and appropriate (e.g., masking).
      4. Monitors HCFP vaccination and immune status and reports relevant metrics as part of patient safety, quality, and other measures.
      5. Designates the facility’s EHC, and provides sufficient training and resources to implement and properly manage the employee health and immunization program, including adjudicating exemption requests.
      6. Authorizes appropriate personnel for access to the employee health record, including the EHC.
      7. May delegate any of the above responsibilities to the facility’s Chief Medical Officer, Clinical Director, or other suitable designee, ensuring accountability while maintaining ultimate responsibility for implementation.
      8. Adjudicates primary appeals for previously denied religious exemption requests submitted by facility HCFP.
      9. Consults with Human Resources and the Office of the General Counsel as necessary to comply with all applicable laws.
   4. Facility Chief Medical Officer or Clinical Director.
      1. Serves as the system manager for the Employee Medical File System.
      2. Designates an individual to oversee day-to-day management of the employee health record.
      3. In coordination with the facility Chief Executive Officer, supports the determination of periods of actual or perceived risk for increased transmission of infectious diseases, including but not limited to COVID-19 and influenza; advises on appropriate mitigating infection control practices as necessary and applicable.
      4. Adjudicates primary appeals for previously denied medical exemption requests submitted by facility HCFP; determines if documentation of vaccinations or immunity is sufficient to meet the requirements of this policy.
      5. Consults with Human Resources and the Office of the General Counsel as necessary to comply with all applicable laws.
   5. Human Resources . Responsible for ensuring that all IHS job announcements include the requirement that a HCFP must comply with IHS’s immunization program requirements and such compliance is a condition of employment. Notices for HCFP positions should explicitly mention the requirements for documented immunity to or receipt of vaccination(s) against infectious conditions listed in section D(2). Applicants must be informed that additional vaccinations may be required depending on later determination of specific occupational risks.
      
      Advises on and assists with disciplinary and related actions for noncomplying HCFP. Ensures compliance with applicable Human Resources processes and requirements.
   6. Employee Health Coordinator .
      1. Annually reviews this and any related IHS policy on employee immunization requirements, including general procedures, appeals processes, and related timing requirements.
      2. Completes sufficient and periodic training (no less than annually) to ensure current, proficient knowledge regarding reasons for medical contraindication to required vaccinations. Training resources may include:
         1. The CDC’s course textbook on the Epidemiology and Prevention of Vaccine-Preventable Diseases (‘Pink Book’).
         2. Recorded webinar training series on CDC’s Pink Book.
      3. Completes sufficient and periodic training (no less than annually) on processes and laws pertaining to reasonable accommodation.
      4. Completes sufficient and periodic training (no less than annually) on the Health Insurance Portability and Accountability Act (HIPAA) and the Privacy Act to ensure proper stewardship of protected health information and personally identifiable information contained within the employee medical folder.
      5. Educates personnel on vaccination benefits, risks, and requirements, as applicable.
      6. Screens current and newly hired personnel and related positions to determine occupational risk and required and/or recommended vaccines.
      7. Maintains records of HCFP vaccinations, serologic immunity testing, or medical or religious exemptions as part of the employee health record in accordance with Indian Health Manual Chapter 3- 3: Health Information Management; and Chapter 1-9, Occupational Safety and Health.
      8. Tracks and reports HCFP immunization status as directed.
      9. Consistent with applicable privacy laws, provides information to supervisors, managers, and leaders regarding compliance with required vaccinations, either for individual HCFP or in aggregate, as directed.
      10. Receives and timely adjudicates initial requests for HCFP medical and religious exemptions and maintains documentary evidence of requests and outcomes; receives and refers appeals of exemption denials as needed to appropriate adjudicating officials. Upon request, consults with adjudicating officials on considerations related to appeals of exemption denials.
      11. Determines if documentation of vaccinations or immunity is sufficient to meet the requirements of this policy.
      12. Consults with Human Resources and the Office of the General Counsel as necessary to comply with all applicable laws.
   7. Supervisors . Coordinates with the EHC as needed to ensure that all requests for accommodations are reviewed in a timely manner and that subordinate personnel comply with this policy.
   8. Health Care Facility Personnel .
      1. Receives required vaccinations, as applicable, and maintains vaccination and/or immune status as required by this policy.
      2. Seeks occupational risk assessment, as needed, to determine any additional required vaccinations.
      3. Provides suitable and timely documentation of vaccination or other evidence of immunity, as needed.
      4. As applicable, in lieu of vaccination, files timely exemption requests and/or renewal of existing exemption from vaccination, and promptly notifies the EHC of any changes in exemption status (e.g., resolution of a temporary medical contraindication precluding vaccination).
8. References .
   1. Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older — United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:11–15. DOI:
      http://dx.doi.org/10.15585/mmwr.mm7301a3
   2. Measles, Mumps, Rubella Vaccine (PRIORIX): Recommendations of the Advisory Committee on Immunization Practices — United States, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1465–1470. DOI:
      http://dx.doi.org/10.15585/mmwr.mm7146a1
   3. Prevention of Hepatitis A Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2020. MMWR Recomm Rep 2020;69(No. RR-5):1–38. DOI:
      http://dx.doi.org/10.15585/mmwr.rr6905a1
   4. Use of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccines: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2019. MMWR Morb Mortal Wkly Rep 2020;69:77–83. DOI:
      http://dx.doi.org/10.15585/mmwr.mm6903a5
   5. Pneumococcal Vaccine for Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR Recomm Rep 2023;72(No. RR-3):1–39. DOI:
      http://dx.doi.org/10.15585/mmwr.rr7203a1
   6. Use of Inactivated Polio Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices
      — United States, 2023. MMWR Morb Mortal Wkly Rep 2023;72:1327– 1330. DOI: 2023;72:1327–1330. DOI:
      http://dx.doi.org/10.15585/mmwr.mm7249a3
9. Supersedure . This chapter supersedes IHS Circular No. 79-06, “Rubella Screening and Immunization for Indian Health Service Employees,” and IHS Circular No. 16-04, “Mandatory Seasonal Influenza Immunizations for Civilian Health Care Personnel.”